• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


             

New Enrollment PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Inadequate
Application Number P170043 / PAS002
Date Current Protocol Accepted 04/30/2020
Study Name New Enrollment PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this post approval study (PAS) is to evaluate the rate of clinically relevant complications associated with iStent inject

placement and stability, as determined at 36 months in the postmarket setting compared to the pre-specified performance

target of 2%. This is a prospective, non-randomized, multicenter, single-arm, post approval study of the iStent inject with follow-up

through 3 years postoperative.
Study Population Description 358 eyes at a minimum of 15 and up to 30 investigational sites in the U.S. It is expected that the enrollment phase will last up to 37.5

months.
Sample Size A sample size of 250 eyes can provide a statistical power of 80% at a true p of 0.05. Considering a drop-out rate of 30% at 36 months for

this post-approval study, the study should treat at least 358 eyes of 358 subjects.

Data Collection The rate of clinically relevant complications associated with iStent inject placement and stability as determined at 36 months.

Specific device-related complications include clinical sequelae resulting from device position including, but not limited to:

Secondary surgical intervention (SSI) to modify device position (e.g., repositioning or explantation)

Corneal endothelial touch by device

Corneal edema leading to BSCVA loss > 2 lines at the Month 36 visit, in comparison with preoperative BSCVA

Other Safety Outcomes:

Rate of occurrence of sight-threatening adverse events including:

Persistent (at time of study exit) BSCVA loss greater than or equal to 3 lines compared to best recorded BSCVA at any postoperative visit

Endophthalmitis

Corneal decompensation

Retinal detachment

Severe choroidal hemorrhage or detachment or aqueous misdirection

Rate of ocular secondary surgical interventions (SSI)

Rate of other adverse events including:

Increase from baseline IOP of greater than or equal to 10 mmHg at any time greater than or equal to 30 days postoperative

BSCVA loss greater than or equal to 2 lines at Month 36 compared to preoperative

BSCVA loss greater than or equal to 2 lines at Month 36 compared to best recorded

BSCVA at any postoperative visit

Device movement, defined as a stent not visible in the original location, that does not result in clinically relevant complications

as described above (e.g., SSI to modify device position, corneal endothelial touch by device, or corneal edema leading to BSCVA loss > 2 lines at the Month 36 visit compared to preoperative BSCVA), and that is not attributable to any one or more of the following:

¿ variations in gonioscopy, OCT or UBM (or other standard imaging methods) viewing angle or illumination

¿ changes in angle anatomy due to concomitant findings such as resolution of hyphema

¿ changes in anterior chamber depth

¿ development of focal peripheral anterior synechiae (PAS)
Follow-up Visits and Length of Follow-up 36 months (3 years)


New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/20/2018 01/15/2019 Overdue/Received
one year report 06/21/2019 06/14/2019 On Time
18 month report 12/20/2019 12/12/2019 On Time
two year report 06/20/2020 06/17/2020 On Time
three year report 06/20/2021    
four year report 06/20/2022    
five year report 06/20/2023    
six year report 06/20/2024    
seven year report 06/20/2025    
final report 06/20/2026    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Related Links

-
-